Sodium Oxybate in Schizophrenia With Insomnia

Completed · Phase 2

Conditions studied: Schizophrenia, Insomnia Related to Schizophrenia (307.42)

In brief

The present protocol proposes study of the recently approved compound sodium oxybate (Xyrem), a gamma-aminobutyric acid type b (GABAB) and a g-hydroxybutyric acid (GHB) receptor agonist, for the study of persistent symptoms of schizophrenia. Sodium oxybate is a central nervous system depressant currently approved for treatment of narcolepsy associated with cataplexy and excessive daytime sleepiness. In addition to evaluating effects on sodium oxybate on persistent symptoms and neurocognitive deficits in schizophrenia, the study will test the hypothesis that this medication may be particularly effective in combating Insomnia Related to Schizophrenia, and in normalizing symptomatic and polysomnographic manifestations of sleep-related brain dysfunction in schizophrenia.

Key facts

Study ID

NCT00594256

Run by

Nathan Kline Institute for Psychiatric Research

People needed

8

Starts

2008-05-01

Expected to finish

2009-04-01

Last updated by the study team

2016-02-08

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18-45 with a DSM-IV diagnosis of schizophrenia and insomnia related to schizophrenia, confirmed by a structured interview (SCID).

You may not qualify if…

• Lack of capacity to give informed consent (capacity is determined by a licensed member of the treatment team).
• Unstable medical illness.
• Diagnosis of restless leg syndrome, a seizure disorder, uncontrolled hypertension, unstable cardiac illness, or obstructive sleep apnea.
• Pregnancy or lack of adequate birth control.
• History of substance dependence disorder.
• Current treatment with valproic acid.
• Succinic semialdehyde dehydrogenase deficiency (SSADH).
• Persistent need for treatment with benzodiazepines, barbiturates, opiates or other sedative hypnotics.

Where it is running

• Nathan Kline Insitute for Psychiatric Research — Orangeburg, New York, United States

Full record on ClinicalTrials.gov

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